PROMIS Evaluation Study

Recruiting

• Conditions: Hip Arthropathy; Osteonecrosis; Osteoarthritis, Hip; Perthes Disease; Femoral Neck Fractures
• Interventions: Device: PROMIS Stem

• Registration Number: NCT05734651
• Lead Sponsor: Bezirkskrankenhaus St. Johann in Tirol

Brief Summary

A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical.

The purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-09
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2026-02-09
• Study Completion: 2042-02-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria

• n/a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	PROMIS Stem	-

Primary Outcome Measures

Name	Time	Method
Stem Migration	20 years	Stem Migration measured with the validated EBRA method. The stem migration is assessed in millimeters. The radiograph before surgery and sequential radiographs after surgery are assessed.

Secondary Outcome Measures

Name	Time	Method
WOMAC Score	20 years	Patient reported outcome score that is assessed before the surgery and one year after the surgery, 5 years after the surgery, 10 years and 20 years after the surgey.

Trial Locations

Locations (1)

BKH St. Johann in Tirol, Department for Orthopedics and Traumatology; 🇦🇹 Sankt Johann In Tirol, Tyrol, Austria